A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Phase 2a Study of Oral IW-9179 Administered Once Daily for 14 Days to Patients with Functional Dyspepsia
- Conditions
- Functional DyspepsiaMedDRA version: 16.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2012-002748-25-NL
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1. Patient has signed an ICF before any study-specific procedures are performed;
2. Patient is a male or non-pregnant, non-breastfeeding female, and is aged 18 years or older at the time of the Screening Visit;
3. Sexually active female patients of childbearing potential must agree to use one of the following methods of birth control from the date they sign the ICF until the EOS Visit:
a. Hormonal contraception (i.e., oral contraceptive, contraceptive implant, or injectable hormonal contraceptive)
b. Intrauterine device
c. A barrier birth control (e.g., condom or occlusive cap with spermicidal
foam/gel/film/cream/suppository)
d. Surgical sterilization (i.e., bilateral oopherectomy, hysterectomy, or tubal ligation)
e. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy;
4. Female patients of childbearing potential must complete a serum pregnancy test with negative results at the Screening Visit and a urine pregnancy test with negative results at the Randomization Visit prior to dosing;
5. Patient meets Rome III criteria for functional dyspepsia at the Screening Visit; in addition,the patient has no evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms:
Criteria for Functional Dyspepsia:
Patient reports at least one of the following symptoms for the previous 3 months, with onset at least 6 months prior to the Screening Visit:
a. Bothersome postprandial fullness, occurring after ordinary-sized meals, more than 1 day per week, and/or
b. Early satiation that prevents finishing a regular meal, more than one day per week, and/or
c. Pain or burning localized to the epigastrium at least once per week;
6. Patient has a normal EGD either during the Screening Period or within 2 years of the Screening Visit, with no evidence of structural or organic disease that may explain the patient’s gastroduodenal symptoms, such as erosive esophagitis, atrophic gastritis, erosive gastroduodenal lesions, hiatal hernia (if the hiatal hernia is < 2 cm, the patient is eligible for the study), Barrett’s esophagus or dysplasia/neoplasia of the esophagus, stomach, or duodenum.
An EGD completed prior to the Screening Visit is only acceptable if the patient has not had a significant change in the frequency, severity or type of epigastric symptoms since completing the test. If the patient has had significant changes in epigastric symptoms, the EGD should be repeated during the Screening Period. If the EGD is performed during the
Screening Period, it must be completed at least 7 days before beginning the Pretreatment Period. It is not required that biopsies be taken as part of the EGD procedure, but biopsy results should be reviewed if they were obtained;
7. Patient reports an average daily score for postprandial fullness at its worst of = 3.0 during the 14 calendar days before the start of the Treatment Period;
8. Patients who EITHER:
a. Have not used a PPI within 4 weeks of the Screening Visit, OR
b. Have used a PPI and/or H2RA at a stable dose for at least 4 weeks prior to the Screening Visit;
NOTE: patients who have used an H2RA during the 4 weeks prior to the Screening Visit, but not at a stable dose, must stop using the medication at least one calendar day prior to the Pretreatment Period, as described in Appendix 1.
9. Patient is compliant with PDA completion, as measured by adequately responding to at least 10 days of PDA questions dur
1. Patient fulfills any of the following criteria related to gastroesophageal reflux disease (GERD):
a. Reports experiencing heartburn (a burning sensation in the chest) and/or regurgitation (the feeling of fluid or food from the stomach coming up into the mouth or throat) on more than 1 day per week during any of the 4 weeks prior to the Screening Visit, or
b. Experiences heartburn an average of more than 2 days per week and has an average daily score for heartburn > 1.0 on an 11-point (0-10) NRS during the 14 calendar days before the start of the Treatment Period;
2. Patient has a history of inflammatory bowel disease, chronic pancreatitis, small intestinal bacterial overgrowth, celiac disease, lactose intolerance, polycystic kidney disease, interstitial cystitis, or scleroderma;
3. Patient has a history of any organic or structural disease that can cause abdominal pain or discomfort, e.g., chronic cholecystitis, biliary colic, symptomatic gallstones, gastric outlet obstruction, pelvic inflammatory disease, endometriosis, ovarian cysts, or chronic
prostatitis. NOTE: Patients who have had definitive (i.e., curative) treatment of the condition are eligible, provided that the definitive treatment occurred at least 1 year before the Screening Visit, and the patient has had no symptoms associated with the condition for
at least 1 year;
4. Patient has a history of significant neurological disease, such as Parkinson’s disease, multiple sclerosis, stroke, or spinal cord injury;
5. Patient has alarm symptoms suggestive of organic gastrointestinal (GI) disease, such as unexplained anemia, unexplained weight loss, GI bleeding, or dysphagia;
6. Patient has diabetes mellitus;
7. Patient fulfills both of the following criteria related to gastroparesis:
a. Patient has a history of a diagnosis of gastroparesis, or the investigator suspects that the patient’s current abdominal symptoms are caused by gastroparesis and
b. Patient experiences unexplained vomiting = 2 times during the 4 weeks prior to the Screening Visit;
8. Patient reports stools described as loose, mushy or watery (Bristol Stool Form Scale [BSFS] score of 6 or 7) >25% of the time during the four weeks prior to the Screening Visit, or during the 14 calendar days before the start of the Treatment Period;
9. Patient has been diagnosed with, or is suspected of having celiac disease;
10. Patient has a thyroid-stimulating hormone (TSH) value outside of the normal range at the Screening Visit, or treated hypothyroidism for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of the Screening Visit;
11. Patient has had surgery that meets any of the following criteria:
a. Surgery of the GI tract (including gastric banding) other than an appendectomy at any time before the Screening Visit
b. An appendectomy or cholecystectomy during the 3 months before the Screening Visit
c. Non-GI surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit
d. Other major non-GI surgery during the 30 days before the Screening Visit;
12. Patient has a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable). Note: patients with a history of cancer are allowed provided that the malignancy has been in remission for at least 5 years before the Screening Visit. A complete remission is defined as the disappearance of all signs of cancer in response to
treatment;
13. Patient has
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method